Oxycodone hydrochloride having less than 25 ppm 14-hydroxycodeinone
AssigneePurdue Pharma L.P.
InventorsRobert Chapman, Lonn S. Rider, Qi Hong, Donald Kyle, Robert Kupper
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Abstract
In certain embodiments the invention is directed to a process for preparing an oxycodone hydrochloride composition having less than 25 ppm of 14-hydroxycodeinone.
Claims19
An oral dosage form comprising particles, the particles comprising from about 5 mg to about 320 mg oxycodone hydrochloride active pharmaceutical ingredient having less than 25 ppm 14-hydroxycodeinone, wherein at least a portion of the 14-hydroxycodeinone is derived from 8α,14-dihydroxy-7,8-dihydrocodeinone during conversion of oxycodone free base to oxycodone hydrochloride, said particles being coated with an amount of hydrophobic material effective to provide a sustained release of the oxycodone hydrochloride when the coated particles are exposed to an aqueous solution.
An oral dosage form comprising (i) from about 5 mg to about 320 mg of oxycodone hydrochloride active pharmaceutical ingredient having less than 25 ppm 14-hydroxycodeinone, wherein at least a portion of the 14-hydroxycodeinone is derived from 8α,14-dihydroxy-7,8-dihydrocodeinone during conversion of oxycodone free base to oxycodone hydrochloride;
- and (ii) a sustained release material, wherein the sustained release material is film coated onto said oxycodone hydrochloride active pharmaceutical ingredient.
An oral dosage form comprising:
- (i) from about 5 mg to about 320 mg of oxycodone hydrochloride active pharmaceutical ingredient having less than 25 ppm 14-hydroxycodeinone, wherein at least a portion of the 14-hydroxycodeinone is derived from 8α,14-dihydroxy-7,8-dihydrocodeinone during conversion of oxycodone free base to oxycodone hydrochloride;
- and (ii) a pharmaceutically acceptable excipient.
Dependencies are inferred from the claim text.